Clinical Trial Manager II – Site Management & Monitoring

About the role

The Clinical Trial Manager II will oversee site management, clinical monitoring and central monitoring activities to ensure patient safety, protocol compliance and data integrity across the study lifecycle.

Key responsibilities

• Manage site interactions from activation through closeout, including recruitment, investigator payments and risk assessments.
• Oversee CRAs and Central Monitors, allocate resources, and monitor study milestones such as activation, enrollment and database lock.
• Develop and maintain clinical study tools, monitoring plans, CTMS dashboards and ensure system readiness (UAT, audit trails).
• Escalate risks to timeline, quality or budget to the Project Manager and propose mitigation strategies.
• Coordinate training on protocol specifics, CRF completion, SOPs and data management plans.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Proven ability to lead teams and align them to project milestones in an international environment.
• Strong understanding of GCP/ICH guidelines, regulatory requirements and clinical trial financial principles.

Required skills

• Experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.
• Familiarity with IVRS/IWRS, eDiary/ePRO systems and central monitoring dashboards.
• Knowledge of risk‑based monitoring and development of monitoring plans.